DeviceClearance

Product code PEM— General, Plastic Surgery

Dental Barrier and Sleeves

Classification name
Dental Barriers And Sleeves
Device class
Class 2
Regulation
21 CFR 878.4370
Advisory panel
General, Plastic Surgery
Total cleared
16
First cleared
Most recent

FDA classification definition

“Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.”

— U.S. Food and Drug Administration, device classification record for product code PEM under 21 CFR 878.4370, via openFDA

Market context for product code PEM

FDA has cleared 16 devices under product code PEM between 2014 and 2026, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PEM

Recent clearances under product code PEM

Data sourced from openFDA. This site is unofficial and independent of the FDA.